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Regulatory Focus™ > News Articles > UK Pharmacovigilance Post-Brexit: Lots of Questions, Few Answers

UK Pharmacovigilance Post-Brexit: Lots of Questions, Few Answers

Posted 01 May 2017 | By Zachary Brennan 

UK Pharmacovigilance Post-Brexit: Lots of Questions, Few Answers

No one knows what UK pharmacovigilance will look like after the UK leaves the EU, and that uncertainty puts the many Qualified Persons Responsible for Pharmacovigilance (QPPVs) residing in the UK in a precarious position.

According to the UK’s independent academic Drug Safety Research Unit, which organized a meeting last week on the topic of pharmacovigilance post-Brexit, "At worst, this will deal a severe blow to UK pharmacovigilance" as pharmaceutical companies "will not be obliged to carry out pharmacovigilance in the UK, and may not ask UK pharmacovigilance providers to carry out these studies."

Currently, the European Medicines Agency (EMA) runs the Pharmacovigilance Risk Assessment Committee (PRAC), which uses two members from each member state and has been chaired since its inception in 2012 by June Raine of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

But following Brexit, the UK will no longer be represented on PRAC, though representatives may present as non-voting observers, as Norway and Iceland currently do.

"Pharmacovigilance is above politics," Saad Shakir, director of the Drug Safety Research Unit, said last week at the "Forum on UK Pharmacovigilance Post-Brexit," according to audio files emailed to Focus.

He also noted the large number of QPPV leaders based in the UK, adding, "We want them to continue to be part of the EU apparatus. These are national assets." But currently, he said, they are "scared stiff about what’s going to happen because the regulations say the QPPV has to reside in the EU."

Shakir added that there might be a negotiated system of mutual recognition or a way for MHRA and EMA to continue collaborations.

Ian Hudson, chief executive of MHRA since 2013, said recently, according to Shakir, that there has been discussion of outsourcing some regulatory work from the UK, but, "We don’t know what that outsourcing will look like."

Virginia Acha of the Association of the British Pharmaceutical Industry also noted that pharmacovigilance sometimes gets the short end of the stick because it works so well currently.

"There is an enthusiasm to maintain much of the status quo, but the degree to which may be possible post-Brexit is not clear," the Drug Safety Research Unit said in a statement. "Once the UK leaves the EU, it is essential that continued collaboration between the UK and Europe in pharmacovigilance is maintained and indeed enhanced. Mutual recognition of pharmacovigilance studies by the MHRA and the EMA is required as part of Brexit negotiations."

In addition to this meeting focusing on UK pharmacovigilance, this past weekend, the European Council set the guidelines for Brexit negotiations between the UK and the EU.


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